Health TrialsbyHealthPanel

Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)

ConditionTriple Negative Breast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Curie

About this trial

CUPCAKE is a randomized, non-comparative, multicenter, proof-of-concept phase II trial, using the Trials within Cohorts concept(1) to assess the clinical utility of ctDNA monitoring combined with 68Ga-FAPI-46-PET-CT imaging upon ctDNA detection for the surveillance of patients with a non-metastatic TNBC at high risk of relapse.

The study has two steps. In Step 1, patients who have completed the treatments for a localized TNBC will undergo ctDNA monitoring every \~4 months (± 2 weeks). In Step 2, patients for whom ctDNA will be detected will then be randomized between an observation arm, in which monitoring will continue until the detection of a clinical relapse, and an experimental arm, in which the ctDNA detection will be revealed to both the patient and the clinician: patients will then undergo a 18F-FDG PET-CT and a 68Ga-FAPI-46-PET-CT, in addition to whatever workup the investigator will deem necessary.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have signed a written informed consent before inclusion

Patients must be female ≥ 18 years old

Patients diagnosed with a non-metastatic TNBC (ER & PR <10%, HER2- per ASCO/CAP guidelines). Patients must have been previously evaluated by a 18F-FDG PET-CT or a bone scintigraphy combined with a thorax, abdomen and pelvis CT scan with contrast

Patients who have undergone surgery with curative intent for their non-metastatic TNBC. Surgery must have been performed between 3 to 24 months before inclusion. Patients must have initiated their adjuvant therapy, whenever indicated, since at least 12 weeks. For patients receiving an experimental adjuvant treatment in a clinical trial, any intervention planned as part of this trial must be completed before inclusion.

Disqualifiers

Any uncontrolled disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding or any other medical condition that, in the opinion of the investigator, interferes with the trial procedures

Male participants

Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.

Patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons

Trial design

Design model

Parallel

Treatments tested in this trial

  • ctDNA monitoring

    Diagnostic test

    For each patient included, a ctDNA detection assay will be performed in blood samples every 4 months, while extra-plasma will be banked. ctDNA results will be available with a turnaround time of less than 3 weeks. When negative, ctDNA detection results will not be disclosed to patients nor clinicians.

  • 68Ga-FAPI-46-PET-CT

    Diagnostic test

    ). To locate metastatic deposits, patients will be offered to undergo a whole-body imaging with 18F-FDG PET-CT and 68Ga-FAPI-46-PET-CT, in addition to any other workup considered as relevant by their treating physician.

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: Experimental armExperimental treatment 2 interventions
Group B: Control armSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival

OS rate for the main analysis (primary endpoint) is defined as the percentage of patients still alive 36 months after the randomization. If the patient is not present at the 36th month visit, survival data may be obtained by other means, such as telephone contact with the patient, his family, his current physician, or consulting local death registries. A non-comparative analysis will be conducted in the experimental arm, and the control arm will serve as reference.

Time frame
36 months

Secondary outcomes

1

Number of metastatic sites at the time of the clinical/radiological relapse.

The number of metastatic sites upon clinical/radiological relapse will be defined post-hoc by the Adjudication Committee as the number of organs or systems in which metastases are detected at the time of the clinical/radiological relapse, among the following propositions: lymph nodes, bones, liver, lungs, central nervous system/meninges, peritoneum, others.

Time frame
Clinical/radiological relapse up to 36 months
2

Recurrence-free survival

RFS \[recurrence-free survival\], defined as the time from randomization to clinical/radiological relapse or death; PFS \[progression-free survival\], defined as the time from randomization to the first progression or death occurring after clinical/radiological relapse; 1L-PFS \[first line PFS\], defined as the time from clinical/radiological relapse to first progression or death ; 2L-PFS \[second line PFS\], defined as the time from first to second progression or death; progression being defined per RECIST criteria.

Time frame
Clinical/radiological relapse up to 36 months
3

Overall response rate

Best ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) based on local investigator assessment according to RECIST 1.1, until first progression or last tumor assessment in the absence of progression. ORR will be reported with its 95% confidence interval by arm.

Time frame
12 months
4

Overal Survival

Overall Survival is defined as the time between randomization and death.

Time frame
Up to 36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Curie

Lead sponsor

National Research Agency, France

Collaborator

Roche Pharma AG

Collaborator

Personalis Inc.

Collaborator

UNICANCER

Collaborator

Source ClinicalTrials.gov
Apply now